Pharmaceutical Technology’s annual equipment and manufacturing survey gained the industry’s perspectives on trends in finished drug-product manufacturing and equipment. Respondents in both solid dosage and parenteral drug manufacturing were generally satisfied with the utility of existing equipment and the pace of innovation in meeting manufacturing needs. Most employ quality by design (QbD) to some extent, but respondents identified a range of challenges in implementing QbD. Responses also indicated trends in high-potency/high-containment manufacturing, process analytical technology (PAT), and continuous manufacturing.

The survey showed that existing solid-dosage equipment is generally meeting needs. Areas noted by more than 20% of respondents as needing significant improvement, however, included process control/automation, powder transfer/materials handling, and feeding/dispensing (see Figure 1). When asked if innovation is keeping pace with current and future needs, responses were similar, with the same three areas indicated as lacking solutions by 20% or more of respondents. Tablet compression stood out as a strongly innovative area, with 96% of respondents indicating that innovation is “excellent” or “good” for this equipment.

Users of parenteral equipment, likewise, are generally satisfied with existing equipment, as shown in Figure 2. Process control/automation and vials/cartridges fill-finish equipment, however, were two areas noted by 20% or more of respondents as needing significant improvement. In all segments, nearly 80-90% of respondents said that the pace of innovation was “good” or “excellent”.

High-containment/high-potency manufacturing

Just over half of respondents that are involved in high-containment/high-potency manufacturing had seen an increase in activity in this area in the past year. Approximately one quarter of respondents said system setup/changeover was the most challenging factor in high-containment/high-potency manufacturing, while another quarter identified getting materials into or out of the contained system during production as the most challenging. Others identified air flow (10%), air-flow changes (10%), environmental issues (10%), containment (10%), personnel protection (7%) and ergonomics (3%) as the most challenging factor in high-containment/high-potency manufacturing.